Aura to Host Virtual Investor Day at 11:30 a.m.
Eastern Time
Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage
biotechnology company developing a novel class of virus-like drug
conjugate (VDC) therapies for multiple oncology indications, today
announced that interim Phase 2 data evaluating the safety and
efficacy of suprachoroidal (SC) administration using its first VDC
product candidate, belzupacap sarotalocan (AU‑011), for the
first-line treatment of patients with early-stage choroidal
melanoma (indeterminate lesions and small choroidal melanoma
(IL/CM)), were presented at the American Academy of Ophthalmology
(AAO) 2022 Annual Meeting held September 30-October 3, 2022, in
Chicago, IL.
“The Phase 2 interim safety and efficacy data that was presented
at AAO is very encouraging for patients with primary choroidal
melanoma, as the majority of patients are diagnosed with
early-stage disease and have no vision-preserving treatment
options. Interim data showed a statistically significant reduction
in tumor growth rate and a robust tumor control response with a
high rate of visual acuity preservation at the therapeutic
regimen,” said Dr. Ivana Kim, Director of the Ocular Melanoma
Center, Massachusetts Eye and Ear. “Belzupacap sarotalocan offers a
favorable safety profile supporting the potential to become the
first vision-preserving treatment for early-stage choroidal
melanoma, where patients have had to rely on radiotherapy for the
last few decades.”
“Preliminary analysis of the data from the Phase 2 trial using
suprachoroidal administration supports tolerability up to three
cycles of therapy and shows a dose-dependent anti-tumor response.
The results provide further clinical evidence to support the
potential use of belzupacap sarotalocan as a novel targeted therapy
in patients with early-stage disease with this targeted route using
suprachoroidal administration,” said Dr. Cadmus Rich, Chief Medical
Officer and Head of R&D of Aura Biosciences. “We believe that
the data to date provides proof of concept for an additional
intraocular route of administration and further supports belzupacap
sarotalocan’s target product profile.”
The presentation can be accessed on the Company’s website:
link
Interim Safety and Efficacy Data from the Ongoing Phase 2
Trial with SC Administration
This Phase 2 trial (NCT04417530) is assessing the safety and
preliminary efficacy of single- and multiple ascending-doses of
belzupacap sarotalocan up to three cycles of treatment via SC
administration for the first-line treatment of early-stage
choroidal melanoma (IL/CM). A total of 20 adult patients have been
enrolled in the trial including the single dose Cohorts 1-3 (n=6)
and multiple dose escalation Cohorts 4-6 (n=14). Cohorts 5 and 6
received up to three cycles of therapy, which was considered the
therapeutic regimen for evaluation. One patient in Cohort 5 (n=3)
received two cycles of therapy and two patients in Cohort 5
received three cycles of therapy (40 μg/dose). All patients from
Cohort 6 (n=8) received three cycles of therapy at the highest dose
(80 μg/dose). One patient from Cohort 6, who discontinued after one
cycle due to unrelated serious adverse events (SAEs), is not
included. All patients in Cohorts 5 and 6 had active growth at
study entry, as an enrichment strategy to evaluate preliminary
efficacy. This group of patients with active growth treated at the
therapeutic regimen of three cycles was evaluated for tumor growth
rate, tumor control, and visual acuity preservation as the defined
clinical endpoints to evaluate preliminary efficacy. These
endpoints have been discussed with the U.S. Food and Drug
Administration and are planned to be used in the pivotal program.
The results, with an average of six months follow up in patients
that received three cycles of therapy in Cohorts 5 and 6, showed a
statistically significant reduction in the tumor growth rate
(-0.296 mm/yr, p = 0.0007) compared to each patient’s documented
growth rate at study entry, and an 88.9% (8/9) tumor control rate.
In addition, the visual acuity preservation rate was 88.9% (8/9) in
these cohorts, with the majority of patients being at high-risk for
vision loss with tumors close to fovea or optic disk. The overall
safety profile of belzupacap sarotalocan was generally favorable,
with no dose-limiting toxicities or treatment-related SAEs reported
as of August 19, 2022. There was no posterior inflammation and only
mild anterior inflammation (Grade 1) in 20% of the patients.
Treatment-related AEs were predominantly mild and resolved without
sequalae. We believe these interim results indicate that belzupacap
sarotalocan may offer a targeted vision preserving therapy for the
first-line treatment of primary CM, where 80% of patients are
diagnosed early and have no approved therapies to date.
Details for the Virtual Investor Day:
The Company will host a virtual Investor Day today at 11:30 a.m.
Eastern Time to discuss belzupacap sarotalocan, its first VDC
product candidate, for the first-line treatment of patients with
early-stage choroidal melanoma. The Company’s executive management
team will be joined by three distinguished ocular oncology thought
leaders:
- Carol Shields, MD, Chief of the Ocular Oncology Service at
Wills Eye Hospital and Professor of Ophthalmology at Thomas
Jefferson University (USA)
- Ivana Kim, MD, MBA, Director of the Ocular Melanoma Center,
Massachusetts Eye and Ear & Associate Professor of
Ophthalmology, Harvard Medical School (USA)
- Martine Jager, MD, PhD, Professor of Ophthalmology, Leiden
University (Netherlands) & Past President of the International
Society of Ocular Oncology and the Association for Research in
Vision and Ophthalmology
To access the virtual Investor Day, please dial (888) 660-6585
(U.S. and Canada) or (929) 203-0858 (international) at least 10
minutes prior to the start time and refer to conference ID 9748492.
A live video webcast will be available in the Investor section of
the Company’s website at
https://ir.aurabiosciences.com/events-and-presentations. A webcast
replay will also be available on the corporate website at the
conclusion of the call.
About Aura Biosciences
Aura Biosciences, Inc. is a clinical-stage biotechnology company
developing virus-like drug conjugates (VDCs), a novel class of
therapies, for the treatment of multiple oncology indications.
Aura’s lead VDC candidate, belzupacap sarotalocan (Bel-Sar;
AU-011), consists of a virus-like particle conjugated with an
anti-cancer agent. Belzupacap sarotalocan is designed to
selectively target and destroy cancer cells and activate the immune
system with the potential to create long-lasting anti-tumor
immunity. Belzupacap sarotalocan is currently in development for
ocular cancers, with an ongoing Phase 2 dose escalation clinical
trial evaluating first-line treatment of choroidal melanoma, a
vision- and life-threatening form of eye cancer where standard of
care with radiotherapy leaves patients with severe comorbidities,
including major vision loss. Aura plans to pursue development of
belzupacap sarotalocan across its ocular oncology franchise
including for the treatment of patients with choroidal metastasis.
In addition, leveraging Aura’s technology platform, Aura is
developing belzupacap sarotalocan more broadly across multiple
cancers, including in patients with non-muscle invasive bladder
cancer (NMIBC). Aura is headquartered in Boston, MA.
For more information, visit aurabiosciences.com, or follow us on
Twitter and LinkedIn.
Forward Looking Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, and other federal securities laws. Any statements
that are not statements of historical fact may be deemed to be
forward looking statements. Words such as “may,” “will,” “could”,
“should,” “expects,” “intends,” “plans,” “anticipates,” “believes,”
“estimates,” “predicts,” “projects,” “seeks,” “endeavor,”
“potential,” “continue” or the negative of such words or other
similar expressions that can be used to identify forward-looking
statements. These forward looking statements include express or
implied statements regarding Aura’s future expectations, plans and
prospects, including, without limitation, statements regarding the
therapeutic potential of belzupacap sarotalocan for the treatment
of cancers including choroidal melanoma; any express or implied
statements regarding the Company’s expectations for the Phase 2
clinical trial belzupacap sarotalocan; and Aura’s expectations
regarding the estimated patient populations and related market
opportunities for belzupacap sarotalocan.
The forward-looking statements in this press release are neither
promises nor guarantees, and investors should not place undue
reliance on these forward-looking statements because they involve
known and unknown risks, uncertainties, and other factors, many of
which are beyond Aura’s control and which could cause actual
results to differ materially from those expressed or implied by
these forward-looking statements, including, without limitation, an
improved quality of life of patients after treatment with
belzupacap sarotalocan; a potential paradigm shift in the approach
to the treatment of choroidal melanoma; the urgent need for a
vision preserving targeted therapy; the potential of belzupacap
sarotalocan compared to the existing standard of care for patients
with choroidal melanoma; uncertainties inherent in clinical trials
and in the availability and timing of data from ongoing clinical
trials; the expected timing for submissions for regulatory approval
or review by governmental authorities; the risk that the results of
Aura’s clinical trials may not be predictive of future results in
connection with future clinical trials; the risk that interim data
from ongoing clinical trials may not be predictive of final data
from completed clinical trials; whether Aura will receive
regulatory approvals to conduct trials or to market products;
whether Aura’s cash resources will be sufficient to fund its
foreseeable and unforeseeable operating expenses and capital
expenditure requirements; risks, assumptions and uncertainties
regarding the impact of the continuing COVID-19 pandemic on Aura’s
business, operations, strategy, goals and anticipated timelines;
Aura’s ongoing and planned pre-clinical activities; and Aura’s
ability to initiate, enroll, conduct or complete ongoing and
planned clinical trials. These risks, uncertainties, and other
factors include those risks and uncertainties described under the
heading “Risk Factors” in Aura’s most recent Annual Report on Form
10-K and Quarterly Report on Form 10-Q filed with the U.S.
Securities and Exchange Commission (SEC) and in subsequent filings
made by Aura with the SEC, which are available on the SEC’s website
at www.sec.gov. Except as required by law, Aura disclaims any
intention or responsibility for updating or revising any
forward-looking statements contained in this press release in the
event of new information, future developments or otherwise. These
forward-looking statements are based on Aura’s current expectations
and speak only as of the date hereof and no representations or
warranties (express or implied) are made about the accuracy of any
such forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20221003005309/en/
Investor and Media: Alex Dasalla Head of Investor
Relations and Corporate Communications adasalla@aurabiosciences.com
Argot Partners Matthew DeYoung aura@argotpartners.com
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